Morphological Changes of Removable Orthodontic Retainers During the Use (NCT06283823) | Clinical Trial Compass
CompletedNot Applicable
Morphological Changes of Removable Orthodontic Retainers During the Use
Italy41 participantsStarted 2021-12-21
Plain-language summary
The retention is one of the stages of orthodontic treatment that aims to keep the teeth in the correct positions after orthodontic treatment. Without a retention phase, there is a tendency for the teeth to return to their initial position (relapse). To prevent relapse, at the end of orthodontic therapy the use of retaining devices to keep the teeth in their ideal position is required. The aim of the study is to analyse whether intraoral aging of removable retention devices can lead to morphological or dimensional changes, and whether or not these changes are related to orthodontic relapse, expressed as a change in the Peer Assessment Rating (PAR) index. The PAR index is an index that allows us to evaluate the relapse after orthodontic treatment. In this study the PAR index will be measured at the start of the retention period (T0), at the three-months follow-up (T1) and at the six months follow-up (T2). In particular, two types of thermoformed retainers with different cutouts will be evaluated to determine whether the presence of higher margins in a type of retainers allows to maintain greater stability over time and, therefore, to confer a mechanical and clinical advantage.
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* young adult patients: 18-35 years;
* Caucasian ethnic group;
* good oral hygiene (evaluated by observing a plaque index \< 20% understood as the sum of the indices of the individual dental elements divided by the number of dental elements considered multiplied by 100);
* patients with normal occlusion Class I occlusion with slight overcrowding and PAR Index less than or equal to 10;
* patients who have received previous orthodontic treatment, with or without stripping;
* patients who have received previous orthodontic treatment with \< 20 orthodontic aligners;
* patients who currently use a thermoprinted mask as a restraint, or who do not use any restraint but who would like to receive one.
Exclusion Criteria:
* patients with chromosomal defects, specific neuropsychological disorder, epilepsy (1);
* patients with systemic diseases and comorbidities;
* bruxist patients;
* patients with hypertrophy of chewing muscles, occlusal parafunctions or joint disorders;
* patients with cognitive disabilities with IQ\<70;
* patients undergoing drug therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.